FDA recall Z-0454-2022

Product

iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.

Reason for recall

The dosage information on the pouch is incorrect; the primary carton label is correct.

Distribution

US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.

Key facts

Status

Terminated

Initiation date

2021-11-10

Report date

2022-01-12

Termination date

2023-02-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0454-2022